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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->肺炎
处方药:处方药
包装规格: 400毫克/20毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
CEREXA
生产厂家英文名:
CEREXA
该药品相关信息网址1:
http://www.teflaro.com/
该药品相关信息网址2:
http://www.drugs.com/teflaro.html
该药品相关信息网址3:
http://www.rxlist.com/teflaro-drug.htm
原产地英文商品名:
TEFLARO 400mg/20ml/vial
原产地英文药品名:
CEFTAROLINE FOSAMIL ACETATE
中文参考商品译名:
TEFLARO 400毫克/20毫升/瓶
中文参考药品译名:
醋酸头孢洛林酯
原产地国家批准上市年份:
2010/10/29
英文适应病症1:
CABP
英文适应病症2:
ABSSSI
临床试验期:
完成
中文适应病症参考翻译1:
社区获得性细菌性肺炎
中文适应病症参考翻译2:
急性细菌性皮肤和皮肤结构感染
药品信息:

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 详细处方信息以本药内容附件PDF文件(201122417472539.pdf)的“原文Priscribing Information”为准
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部分中文Teflaro处方资料(仅供参考)

    美国食品药品管理局(FDA)2010年10月29日批准注射用抗生素Teflaro(ceftaroline fosamil)用于治疗成人社区获得性细菌性肠炎(CABP)和急性细菌性皮肤和皮肤组织感染(ABSSSI),包括甲氧西林耐受性金黄色酿脓葡萄球菌(MRSA)感染。
    Teflaro属于头孢菌素类抗菌因子,通过破坏细菌的细胞壁而发挥作用。
    在18岁及以上患者中进行的四项Ⅲ期临床试验(CABP两项,ABSSSI两项)证实了Teflaro的安全性和有效性。CABP试验的对照品为罗氏芬(头孢三嗪),ABSSSI试验的对照品是稳可信(万古霉素)和Azactam(氨曲南)。
    在CABP的两项试验中,1231名成年患者分别接受了Teflaro或Rocephin(罗氏芬,头孢三嗪)。主要的分析终点设为用药第4天基于改善肺炎体征和症状的临床响应。两例试验中,Teflaro的效果均与Rocephin的效果相当。Teflaro常见的不良反应包括腹泻、恶心、皮疹,不应用于头孢菌素类抗生素过敏者
为了减少耐药细菌的发展和保持Teflaro和其他抗菌药物的有效性,Teflaro只应用于为治疗已被证明或强烈怀疑是由细菌引起的感染。

适应证和用途
Teflaro是一种头孢菌素抗菌药适用于由指定的敏感细菌以下引起的感染的治疗:
急性细菌性皮肤和皮肤结构感染(ABSSSI)
社区获得性细菌性肺炎(CABP)

剂量和给药方法
在 ≥ 18岁成年中600 mg每12小时通过1小时IV输注给药
在有肾损伤患者中调整剂量
 
剂型和规格
600 mg或400 mg无菌Teflaro粉在单次使用20 mL小瓶中。

禁忌证
已知对ceftaroline或头孢菌素类的其他成员严重超敏性。

警告和注意事项
(1)曾报道用β-内酰胺抗生素,包括ceftaroline严重超敏性(过敏的)反应。已知对β-内酰胺抗生素超敏性患者谨慎对待。
(2)用几乎所有全身抗菌药物,包括Teflaro曾报道艰难梭菌相关腹泻(CDAD)。如发生腹泻评价。
(3)曾报道用Teflaro直接Coombs’试验血清转化。治疗期间或后如发生贫血。应进行诊断检查对药物诱发溶血性贫血和考虑停止Teflaro。

不良反应
最常见不良反应发生率 >2 %患者是腹泻,恶心,和皮疹。

在特殊人群中的使用
有中度患者或严重肾损伤和肾病终末期ESRD患者, 包括血液透析患者需要调整剂量。

Teflaro
Generic Name: ceftaroline fosamil
Date of Approval: October 29, 2010
Company: Forest Laboratories, Inc.
Treatment for: Community-Acquired Bacterial Pneumonia; Acute Bacterial Skin and Skin Structure Infection

FDA Approves Teflaro
The United States Food and Drug Administration (FDA) has approved Teflaro (ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

What is Teflaro?
Teflaro is a broad-spectrum bactericidal cephalosporin with activity against both gram-positive pathogens and gram-negative pathogens. Teflaro is indicated for the treatment of CABP, including cases caused by Streptococcus pneumoniae bacteremia, and ABSSSI, including cases caused by MRSA.

Teflaro Clinical Study Results
FOCUS I and FOCUS II Phase 3 Clinical Study Results
FOCUS I and FOCUS II studied adult patients who were hospitalized with moderate to severe CABP requiring treatment with intravenous antimicrobials.

To evaluate the treatment effect of Teflaro, a responder analysis was conducted in CABP patients. A responder was defined as a patient who on Day 4 of therapy was in stable condition based on accepted clinical criteria; this was defined as normalization of vital signs and improvement from baseline on at least one respiratory symptom (cough, dyspnea, pleuritic chest pain, or sputum production) while not worsening on any of these four respiratory symptoms. This analysis of the pivotal trial data served as an important element of the FDA's efficacy evaluation.

In FOCUS I, Teflaro-treated patients had a response rate of 69.6% compared with a response rate of 58.3% for ceftriaxone-treated patients on Day 4. In FOCUS II, Teflaro-treated patients had a response rate of 69% compared with a response rate of 61.4% for ceftriaxone-treated patients on Day 4.

The protocol-specified analyses included clinical cure rates at the test of cure (TOC; 8-15 days after end of therapy). In FOCUS I, Teflaro-treated patients had a clinical cure rate of 86.6% compared with a rate of 78.2% in ceftriaxone-treated patients in the clinically evaluable (CE) population. In FOCUS II, Teflaro treated-patients had a clinical cure rate of 82.3% compared with a rate of 77.1% in ceftriaxone-treated patients in the CE population.

CANVAS I and CANVAS II Phase 3 Clinical Study Results
The CANVAS I and CANVAS II trials evaluated Teflaro monotherapy versus vancomycin plus aztreonam in adult patients with complicated skin and skin structure infections caused by gram-positive and gram-negative bacteria.

To evaluate the treatment effect of Teflaro, a responder analysis was conducted in ABSSSI patients with either a major abscess with ‰¥ 5 cm of surrounding erythema, wound infection, or deep/extensive cellulitis requiring treatment with IV antimicrobials. A responder was defined as a patient who on Day 3 achieved both cessation of lesion spread and absence of fever.

In CANVAS I, Teflaro-treated patients had a response rate of 74% compared with a response rate of 64.6% for vancomycin plus aztreonam-treated patients on Day 3. In CANVAS II, Teflaro-treated patients had a response rate of 74% compared with a response rate of 68.1% for vancomycin plus aztreonam-treated patients on Day 3. This analysis of the pivotal trial data served as an important element of the FDA's efficacy evaluation.

The protocol-specified analyses included clinical cure rates at the TOC (8-15 days after the end of therapy). In CANVAS I, Teflaro-treated patients had a clinical cure rate of 91.1% compared with a rate of 93.3% in vancomycin/aztreonam-treated patients in the CE population. In CANVAS II, Teflaro-treated patients had a clinical cure rate of 92.2% compared with a rate of 92.1% in vancomycin/aztreonam-treated patients.

Safety
Each of the studies also indicated that Teflaro was well-tolerated. The overall rate of adverse events was comparable between the two treatment groups. The overall discontinuation rate for Teflaro-treated patients was 2.7% compared to a rate of 3.7% for the comparator group-treated patients. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash.

Teflaro Indications
Teflaro is indicated for the treatment of acute ABSSSI caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca

Teflaro is also indicated for the treatment of CABP caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

Teflaro Contraindications
Known serious hypersensitivity to Teflaro or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

Warnings and Precautions
Hypersensitivity Reactions
Serious hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibiotics, including ceftaroline. Exercise caution in patients with known hypersensitivity to beta-lactam antibiotics including Teflaro. Before therapy with Teflaro is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to penicillin or other beta-lactam-allergic patient, caution should be exercised because cross sensitivity among beta-lactam antibacterial agents has been clearly established. If an allergic reaction to Teflaro occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures, that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated.

Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all antibacterial agents including Teflaro, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.

Development of Drug-Resistant Bacteria
Prescribing Teflaro in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Direct Coombs Test Seroconversion
In the pooled Phase 3 CABP trials, 51/520 (9.8%) of patients treated with Teflaro compared to 24/534 (4.5%) of patients treated with ceftriaxone seroconverted from a negative to a positive direct Coombs' test result. No clinical adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with Teflaro, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of Teflaro should be considered and supportive care should be administered to the patient if clinically indicated.

Drug Interactions
No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil. In vitro studies in human liver microsomes indicated that neither ceftaroline fosamil nor ceftaroline inhibits the major cytochrome P450 isoenzymes. Therefore neither ceftaroline fosamil nor ceftaroline are expected to inhibit or induce the clearance of drugs that are metabolized by these metabolic pathways in a clinically relevant manner.

Use in Specific Populations
For pregnant or nursing mothers, ceftaroline fosamil should only be used if the potential benefit outweighs the potential risk to the fetus or child.

Safety and effectiveness in pediatric patients has not been studied.

Because elderly patients greater-than or equal to 65 years of age are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group as in younger patients with impaired renal function

Dosage adjustment is required in patients with moderately (30 to ‰¤ 50 mL/min) or severely (< 30 mL/min) impaired renal function

The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established

Teflaro side effects
No adverse reactions occurred in greater than 5% of patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash.

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 详细处方信息以本药内容附件PDF文件(201122417472539.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

2011-2-25更新

更新日期: 2011-2-25
附件:






201122417472539.pdf    

 
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